Zydus recalls oversized - 2mg Warfarin Tablets

By: Pharma News | Views: 2965 | Date: 26-Aug-2013

Zydus Pharmaceuticals USA has recalled one lot of 2mg Warfarin tablets as they were oversized. As the company realized that oversized pills could lead to an increased pharmacological effect of the drug, it has voluntarily announced for the recall of the lot #MM5767. While the company noted there were no reports of adverse events or any product complaints, it was announced that the recall is being made as a precautionary measure.

Zydus recalls oversized -2mg Warfarin tablets

Zydus Pharmaceuticals USA has recalled one lot of 2mg Warfarin tablets as they were oversized. As the company realized that oversized pills could lead to an increased pharmacological effect of the drug, it has voluntarily announced for the recall of the lot #MM5767. While the company noted there were no reports of adverse events or any product complaints, it was announced that the recall is being made as a precautionary measure.

According to the USFDA recall notice, as the tablets were oversized, there were chances that patients would be likely to develop bleeding as an adverse reaction and that bleeding into any critical organ could have been fatal. Also, the risk of bleeding increases if the oversized tablets are consumed on a daily basis.

The product was distributed nationwide between November and December 2012. Doctors, pharmacies and hospitals have been requested to stop the use of this lot and patients also need to make sure that the tablets are of the same size and consult the doctor if unsure. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by mail or by fax.